Department of Health and Human Services June 25, 2020 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Community- Acquired Bacterial Pneumonia: Developing Drugs for Treatment.'' The purpose of this guidance is to assist sponsors in the clinical development of antibacterial drugs for the treatment of community- acquired bacterial pneumonia (CABP) based on comments that were received and current recommendations. This guidance finalizes the draft guidance of the same title issued on January 10, 2014.

This notice announces the next meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM). SACATM is a federally chartered external advisory group of scientists from the public and private sectors, including representatives of regulated industry and national animal protection organizations. SACATM advises the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), and the Director of the National Institute of Environmental Health Sciences (NIEHS) and NTP regarding statutorily mandated duties of ICCVAM and activities of NICEATM. This SACATM meeting will be held by webcast only and available to the public for remote viewing. Registration is required to access the webcast and to present oral comments. Information about the meeting and registration are available at https://ntp.niehs.nih.gov/go/32822.

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 12 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.